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Not yet recruitingNCT07765966POPULUS-1Updated Sep 23, 2026

Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias

A Phase 1 interventional study of RXIM002 in Immune Thrombocytopenia (ITP), sponsored by RiboX Therapeutics Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by RiboX Therapeutics Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias.

02

Conditions studied

  • Immune Thrombocytopenia (ITP)

Keywords

  • Relapsed or refractory autoimmune cytopenias
  • Immune Thrombocytopenia (ITP)
  • Circular ribonucleic acid
  • Chimeric Antigen Receptor (CAR)
  • Anti-human CD19
  • in vivo CAR-T therapy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-75 years of age
  • Diagnosed with primary ITP
  • Relapsed or refractory ITP

Exclusion criteria

Exclusion Criteria:

  • Allergy or hypersensitivity to messenger ribonucleic acid (mRNA) vaccines or other RNA-LNP products
  • Any active infection
  • Heart failure, reduced kidney function, or liver abnormalities
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    RXIM002

    Open-label, single arm with 3 dose-level cohorts of RXIM002

    Biological: RXIM002

Interventions

  • BiologicalRXIM002

    Targeted lipid nanoparticle (tLNP)-delivered circular ribonucleic acid (circRNA) encoding an anti-human CD19 chimeric antigen receptor (CAR)

05

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Incidence of treatment-emergent adverse events

    Time frame: Up to 104 weeks

  2. Dose-limiting toxicities (DLTs)

    Dose-limiting toxicities (DLTs)

    Time frame: Through Day 28 post-first dose

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07765966
Lead sponsor
RiboX Therapeutics Ltd.
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

RiboX Therapeutics Ltd.
Contact
RiboX_POPULUS-1_RX-AID-CS102_Study_Mailbox@ribox-tx.com
617-999-8257

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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